Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

NCT ID: NCT03470337

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-09-30
• Study Completion Date: 1997-06-30

Brief Summary

Oral enzyme therapy in patients with acute superficial vein inflammation (thrombophlebitis) can serve as an additional treatment option besides standard therapy with compression stockings, common pain medication and physical treatments. This randomized, double-blinded trial compares efficacy and safety with placebo.

Detailed Description

Enzymes are absorbed in the small intestine and taken up into the bloodstream, at least to some extent. There, they act in an anti-inflammatory manner, as was first described for the serine protease trypsin. Similarly, the cysteine protease bromelain, extracted from the stems of pineapples, is an effective phytotherapeutical drug with anti-inflammatory properties.Proteases have also been indicated to show a certain improvement of the fluidity of the blood. An additional component of the oral enzyme combination can be rutoside, or rutin, a flavonoid known to have cytoprotective and anti-inflammatory properties.

Conditions

Thrombophlebitis Leg

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Phlogenzym

Treatment with German licensed drug Phlogenzym (6 tablets/day)

Group Type: EXPERIMENTAL

Phlogenzym

Intervention Type: DRUG

Bromelain / Trypsin / Rutoside

Placebo

Placebo equates Phlogenzym but without active ingredients

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Phlogenzym

Bromelain / Trypsin / Rutoside

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

Wobenzym plus

Eligibility Criteria

Inclusion Criteria

• male ог female patients with thrombophlebitis in the upper extremities (with ог without varicosis);
• age ~ 18 years;
• acute thrombophlebitis in the lower leg
• moderate to severe pain as monitored on a visual analog scale (VAS, value ≥ 3 cm)
• pain under pressure
• presence of at least three of the following symptoms: skin redness, hyperthermia, phlebitic cords, feeling of heaviness and tenseness.

Exclusion Criteria

• known deep phlebothrombosis
• flourishing ulcus cruris
• arterial occlusive disease
• peripheral neuropathy
• malignant disease
• concomitant concomitant treatment ог а therapy which ended less than 7 days before baseline with corticosteroids, diuretics, anticoagulative agents, platelet aggregation inhibitors and systemic/topical use of anti-inflammatory agents, other preparations for veins and analgesics;
• known intolerance against the active ог the inactive ingredients of the study medication (especially lactose);
• pregnancy
• lactation,
• known alcohol or drug abuse
• participation in another clinical study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mucos Pharma GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcel Baumueller, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Gerhard Stauder, Dr

Role: STUDY_DIRECTOR

Mucos Pharma GmbH & Co. KG (EX)

Locations

Dr. Baumueller

Fano, , Italy

Countries

Italy

Other Identifiers

MU-696414

Identifier Type: -

Identifier Source: org_study_id